Package – Validation Templates and SOP – Basic Package

Addresses the requirements for computer systems validation and includes sections on validation deliverables, roles and responsibilities, and quality assurance controls.

The FRS documents the functionality required for intended use of the system. It contains detailed feature list and will be used in development, configuration, and test creation.

The IQ documents the installation, configuration and associated verification of a system, system components, or supporting peripherals.

The System Design documents how the system will meet the FRS through design of system architecture, data structures, data flows, features, and interfaces.

The OQ/PQ Validation Protocol is used to document the system's ability to meet the functional requirements specifications (OQ) and user requirements specifications (PQ).

The Testing Plan is used to document the validation testing methodology, strategy, tools, environments, and responsibilities. It includes the plan for IQs, OQs, and PQs.

The Trace Matrix documents the adequacy of test coverage by mapping the links between user requirements, functional requirements, and tests, e.g. OQs and PQs.

The URS communicates the business' needs and intended uses of the system to the technical community. Include requirements for data, features, performance, etc.

The Validation Plan describes the validation deliverables, testing approach, and schedule. It also defines responsibilities for creating and approving each validation deliverable.

The Validation Report documents the validation approach and conclusion that the system is certified for operational use based on the validation testing results.

This Validation Incident Report template is used to document the occurrence and resolution of incidents encountered during software validation testing. Basic version.

The Testing Summary documents the results of the validation testing. It includes the testing strategy, IQ, OQ, and PQ results, analysis of failures, and testing conclusion.